Patient Medication Information: uses, side effects, how to take - Vyxeos
Serious Warnings and Precautions
VYXEOS has different dosing directions than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection and cytarabine liposome injection. Your healthcare professional will make sure you are getting the right drug and dose before giving you VYXEOS. If you think you may have received a different drug than usual, talk with your healthcare professional.
What is VYXEOS used for?
VYXEOS is used to treat:
adults with newly diagnosed acute myeloid leukemia (a cancer of the white blood cells). VYXEOS is given when:
- the leukemia is caused by previous treatments. This is known as therapy related acute myeloid leukemia.
- there are certain changes in the bone marrow, which is the spongy tissue inside your bones. This is known as acute myeloid leukemia with “myelodysplasia-related changes”.
How does VYXEOS work?
VYXEOS is part of a group of medicines called “antineoplastics” used against cancer. It contains two medicinal ingredients: daunorubicin and cytarabine. These two medicinal ingredients are packaged in tiny particles known as liposomes. VYXEOS is believed to kill cancer cells by stopping them from growing and dividing. Packaging the medicinal ingredients in liposomes allows the drug to stay longer in the body. The liposomes packaging also helps the drug enter the body and kill the cancer cells.
What are the ingredients in VYXEOS?
Medicinal ingredients: daunorubicin, cytarabine
Non-medicinal ingredients: cholesterol, copper gluconate, distearoylphosphatidylcholine, distearoylphosphatidylglycerol, sucrose, triethanolamine
VYXEOS comes in the following dosage forms:
Powder; 44 mg of daunorubicin and 100 mg cytarabine encapsulated in liposomes
Do not use VYXEOS if:
- you are allergic to daunorubicin or cytarabine, or to any of the other ingredients of this drug. If you are not sure about this, talk to your healthcare professional before taking VYXEOS
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VYXEOS. Talk about any health conditions or problems you may have, including if you:
- Have ever had a heart problem or heart attack, radiation therapy for cancers in the chest, are currently taking cancer medicines that damage the heart, or you have previously taken “anthracycline” cancer medicines. If this applies to you, your doctor may check your heart before starting, and during treatment. Your healthcare professional may end your treatment with VYXEOS depending on the condition of your heart.
- Have any allergic reactions. Your doctor may pause or stop treatment or slow the rate of your drip (infusion), if any allergic reactions occurs.
- Have had problems with your kidneys or liver. Your doctor will monitor you during treatment.
- Have ever had a condition known as Wilson’s disease or other copper-related disorder, as VYXEOS contains an ingredient known as ‘copper gluconate’.
- Are to be given a vaccine. Taking VYXEOS while getting a vaccine may result in a serious or fatal infection.
Other warnings you should know about:
Treatment with VYXEOS can increase your risk of certain side effects, including:
- Tissue death (Tissue necrosis). Tissue death may occur in the surrounding tissue where VYXEOS is injected.
- Inflammation/swelling of the digestive tract and/or diarrhea. This may impact your ability to absorb any medicines you are taking orally (through the mouth).
A large decrease in the production of blood cells and platelets by the bone marrow. Low amounts of platelets may result in serious or fatal bleeding problems. Your healthcare professional:
- will perform blood tests before and during your treatment
- may also give you medicines to help stop you from getting an infection
- will check you for infections during your treatment
Pregnancy and breastfeeding:
If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
- Avoid becoming pregnant while you are taking VYXEOS. It may harm your unborn baby.
- If you are able to become pregnant, your healthcare professional will do a pregnancy test before you start treatment with VYXEOS. This test must show that you are not pregnant.
- Use effective birth control during treatment and for at least 6 months after your last dose of VYXEOS. Talk to your healthcare professional about birth control methods that may be right for you during this time.
- Tell your healthcare professional right away if you become pregnant or think you may be pregnant during treatment with VYXEOS.
- If you are breastfeeding or plan to breastfeed. It is not known if VYXEOS passes into your breast milk. Do not breastfeed during treatment with VYXEOS. Talk to your doctor about the best way to feed your baby during this time.
Male Patients
- During your treatment with VYXEOS, use a condom each time you have sex with a woman who is pregnant, may be pregnant or could get pregnant. Continue using condoms until 6 months after your last dose.
- If, during your treatment with VYXEOS, your sexual partner becomes pregnant or thinks she may be pregnant, tell your healthcare professional right away.
Male Patients - Fertility:
VYXEOS may affect your fertility. This means that it may be difficult for you to have a child. Talk to your healthcare professional if you have questions about this.
Monitoring and Tests:
VYXEOS may cause you to have higher levels of uric acid in your blood. Your healthcare professional will monitor your uric acid levels by performing blood tests during your treatment with VYXEOS.
Driving and using machines:
You may feel sleepy or dizzy after having VYXEOS. If this happens, do not drive or use any tools or machines.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with VYXEOS:
- Cancer medicines that can affect your heart, such as doxorubicin.
- Medicines that can affect your liver.
How to take VYXEOS:
- VYXEOS will be given to you by a healthcare professional who is experienced in treating AML.
- VYXEOS has a different dosing directions than other daunorubicin and cytarabine injection drugs. VYXEOS should not be switched with other daunorubicin and cytarabine drugs.
- You may be given medicines to treat nausea and vomiting before you are given VYXEOS. You may also be given a medicine that will prevent an increase of uric acid levels.
- It will be infused into your vein. It will be infused over a period of 90 minutes.
VYXEOS should be handled and disposed of with special care as it is a cytotoxic agent.
Usual dose:
- Your doctor will calculate your dose of VYXEOS based on your weight and height.
- Your treatment will be given in “courses” or “cycles” of infusions. Each course is given as a separate set of infusion and can be given weeks apart.
- You will receive a first course of treatment and your doctor will decide if you will receive further courses of treatment. This will depend on how you respond to treatment and any side effects you may experience. Your doctor will assess how you respond to treatment after each course.
The recommended dosing schedule is the following:
- During your first course - you will have an infusion on days 1, 3 and 5.
- On any further course (if needed) - you will have an infusion on days 1 and 3.
Overdose:
| If you think you or the person you are caring for, have been given too much VYXEOS, contact a healthcare professional or hospital emergency department immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you miss an appointment to receive your dose of VYXEOS, contact your health professional as soon as possible.
What are possible side effects from using VYXEOS?
These are not all the possible side effects you may feel when taking VYXEOS. If you experience any side effects not listed here, contact your healthcare professional.
- Abdominal pain, stomach cramps, excessive gas, reflux
- Anxiety, confusion or reduced awareness
- Blurred or impaired vision
- Bruising or bleeding without injury
- Chills
- Constipation
- Cough
- Diarrhea
- Dizziness
- Dry eye, eye swelling, eye pain, red eyes or itchy eyes
- Fatigue
- Fever
- Hemorrhoids
- Headache
- Hearing problems
- Itching, red skin, rash
- Loss of appetite
- Muscle pain, joint pain, bone pain
- Nausea and vomiting
- Pain around injection site
- Pinpoint, round spots that appear on the skin
- Sleep problems
- Swelling, including of the arms and legs
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
VERY COMMON Infections, including in the:
fever; chills; sore throat; cough; mouth ulcers. | ✓ | ||
| Febrile neutropenia (low white blood cells): fever, often with other signs of infection | ✓ | ||
| Non-conduction Cardiotoxicity (damage to the heart muscle): chest pain | ✓ | ||
| Hemorrhage (bleeding): bruising; nosebleed; brain hemorrhage | ✓ | ||
| Chest pain | ✓ | ||
| Shortness of breath/difficulty breathing | ✓ | ||
| Arrhythmia (abnormal heart rhythms): irregular or rapid heartbeat; palpitations (feeling of the heart pounding or racing); shortness of breath; chest pain | ✓ | ||
| Mucositis (inflammation of the mouth, stomach or intestine): mouth ulcers; altered taste; loss of appetite; difficulty to eat or talk; red or swollen mouth and gums; pain in the abdomen (belly); constipation; diarrhea | ✓ | ||
| Hypersensitivity (allergic reaction): redness of skin; rash; itching; swelling; fever | ✓ | ||
| Kidney problems: often without symptoms; decreased urination; body swelling; abdominal or lower back pain; nausea; fatigue; loss of appetite | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Transfusion reactions: (present as adverse signs or symptoms during or within 24 hours of a blood transfusion) fever; chills; pruritus or urticaria | ✓ | ||
| Pleural effusion (fluids around the lungs): shortness of breath; chest pain; fever; cough | ✓ | ||
| Hypoxia (low oxygen in tissues): shortness of breath while resting or after physical activity; waking up out of breath; wheezing | ✓ | ||
| Hypotension (low blood pressure): dizziness; light-headedness; blurred vision; weakness; fatigue; nausea (feeling sick); palpitations; headache; cold and/or pale skin | ✓ | ||
| Hypertension (high blood pressure): generally without symptoms; headache; nosebleeds; shortness of breath | ✓ | ||
COMMON Thrombocytopenia (low platelets) which may lead to anemia: tiredness; weakness | ✓ | ||
RARE Pneumonitis (inflammation of the lungs): difficulty breathing; shortness of breath; dry cough; fatigue; loss of appetite | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Hypothyroidism (underactive/low thyroid): Weight gain; tiredness; hair loss; muscle weakness; feeling cold; dry skin; constipation; puffy face; heavier than normal or irregular menstrual periods; enlarged thyroid gland | ✓ | ||
| Hallucinations: seeing or hearing things that are not there | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store in a refrigerator, in its original packaging to protect from light, at a temperature between 2°C to 8°C. Keep in an upright position.
Do not use VYXEOS after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Once reconstituted and diluted for use, the infusion storage should not exceed 4 hours at 2°C to 8°C. VYXEOS should not be used if the solution is cloudy or contains particles.
Keep out of reach and sight of children.
If you want more information about VYXEOS:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.jazzpharma.com, or by calling 1-800-520-5568.
Imported by: Jazz Pharmaceuticals Canada Inc. 4080 Confederation Parkway, Suite 602 Mississauga, Ontario L5B 0G1